Table 1.
Peretinoin clinical studies.
| Protocol | Phase | Endpoints | Subjects | Design | Number of Subjects |
|---|---|---|---|---|---|
|
Muto et al.
(1996) |
Post-curative treatment of HCC (HBV, HCV, NBNC) | Randomized, double blinded, placebo control | 89 | ||
|
NIK-333-01
(Japan) |
I | PK, safety | Post-curative treatment of HCC (HBV, HCV, B+C, NBNC) | Open label | 33 |
|
NIK-333-02
(Japan) |
I | Gene expression, PK, safety | Post-curative treatment of HCC (HCV) | Randomized, parallel group, open label | 12 |
|
NIK-333-03
(Japan) |
II/III | Efficacy, safety | Post-curative treatment of HCC (HCV) | Randomized, double blinded, parallel group, placebo control | 401 |
|
K-333-1.01EU
(UK) |
I | PK, safety | Japanese and Caucasian males volunteer | Open, crossover, single administration/ Double-blind, randomized, parallel-group, placebo-controlled, repeated administration | 41 |
|
K-333-07
(JAPAN) |
I | PK, Safety on QT/QTc interval | Healthy male volunteer | double-blind, randomized, placebo- and positive-control | 56 |
|
NIK-333-05
(Japan) |
III (ongoing) | Efficacy, safety | Post-curative treatment of HCC (HCV) | Randomized, double blinded, parallel group, placebo control | 600 |
|
K-333-06
(Japan) |
III (ongoing) | Efficacy, safety | Post-curative treatment of HCC (HBV) | Randomized, double blinded, parallel group, placebo control | 100 |
|
K-333-3.01A
(KR/TW/SG) |
III (ongoing) | Efficacy, safety | Post-curative treatment of HCC (HBV or HCV) | Randomized, double blinded, parallel group, placebo control | 600 |
HCC, hepatocellular carcinoma—HBV, hepatitis B virus—HCV, Hepatitis C virus—NBNC, non-B non-C—PK, pharmacokinetics—EU, European Union—UK, United Kingdom—KR, Republic of Korea—TW, Taiwan—SG, Singapore.